Study phase:

During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).

Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Subjects for this study will have been diagnosed with a bulge or aneurysm in their abdominal aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most of the lower body including major organs and the legs.

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair the aneurysm.

The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk the aneurysm will be repaired by putting a graft in place of the aneurysm. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm.

The upper portion of the graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) that allow the graft to be located above the renal arteries without blocking blood flow to them. These small holes or branches are the investigational part of this research study. This is needed when there is not enough healthy aorta below the renal arteries. At least one artery may also be treated with an alignment stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft will be referred to as the Zenith Fenestrated-Branched System.

Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to repair an aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

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